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news.Pain Therapeutics and King Pharmaceuticals have announced that the new drug application for Remoxy was accepted and granted priority review by the FDA.
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Remoxy, an investigational drug, is reported to be an abuse-resistant, controlled-release oxycodone for moderate-to-severe chronic pain. If approved, the companies believe Remoxy could be the first oxycodone on the market that is designed to reduce the risk of misuse and abuse.
The FDA typically grants priority review to drug candidates that have the potential to demonstrate significant improvements compared to marketed products.
The FDA goal for completing review of a drug with priority review status is six months from the date the application was submitted. The Remoxy new drug application was submitted to the FDA on June 10, 2008.